E-DRUG: The Safety of Newly Approved Medicines (contd)
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Statement by Sidney M. Wolfe, M.D.
Director, Public Citizen's Health Research Group about
FDA Article in the 5/12/99 Issue of the JAMA:
The Safety of Newly Approved Medicines
The Editorial by Dr. Alastair Wood accompanying the FDA article
repeatedly calls for seeking more information about the circumstances of
the withdrawal of the five drugs highlighted in the FDA article,
requesting an "open public attempt to define what happened."
Unfortunately, the FDA itself has whitewashed this serious problem by
selectively providing only the information in their article which
exonerates the agency from blame in the approval or failure to earlier
withdraw these five drugs.
Fenfluramine and dexfenfluramine: The FDA focuses entirely on the valvular
heart disease which ultimately caused the agency to take these drugs off the
market. There was no mention of hundreds of cases of oft-fatal primary
pulmonary hypertension caused by these drugs, known prior to the 1996
approval of Redux (dexfenfluramine), which many doctors on FDA's advisory
committee were so concerned about that they initially voted against
approval. There was also opposition within the FDA to the approval of Redux.
Terfenadine (Seldane): At least two years before this drug was taken off the
market, the FDA was aware of a large number of cases of fatal or near-fatal
heart arrhythmias caused by its use in combination with other drugs. But, as
Dr. Wood points out, the agency waited until the manufacturer could gain
approval of a less-toxic metabolite of the drug so as to minimize its
marketing losses although this delay prolonged the risks of death to those
using the drug after it should have been taken off the market.
Mibefradil (Posicor): Early results of a study of this drug for treatment of
heart failure--known to the FDA before approval--had shown an increased
number of sudden cardiac deaths in people using the drug, prompting one of
the three members of FDA's advisory committee who opposed the approval to
state, prior to approval, that "aren't we obligated to provide some
assurance the ECG [electrocardiogram] changes we've seen are not ultimately
lethal?" He advocated waiting for approval until the end of the trial, whose
later results helped to propel the drug off the market, only after 600,000
people were subjected to its dangers.
Bromfenac (Duract) : The amount of liver toxicity known to the FDA before
approval caused a cancellation of planned use of this drug for treating
arthritis and the FDA doctor in charge of the drug recommended a box warning
about liver damage when the drug came on the market. He was overruled.
None of these drugs were breakthrough drugs and the serious safety concerns
should have prevented their approval in the cases of Redux, Posicor, and
Duract and a caused a much earlier market withdrawal for Seldane. FDA's
conclusion that there is no problem associated with these drug safety
withdrawals should not be taken seriously because to do so will continue to
jeopardize the safety of American patients.
Sidney Wolfe, M.D.
Public Citizen's Health Research Group
1600 20th St. NW
Washington, D.C. 20009
Phone: 202 588-1000
Fax: 202 588-7796
e-mail swolfe@citizen.org Web Site: www.citizen.org
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